around the world. In NC, we operate three medical manufacturing facilities that are responsible for fulfilling different steps in our injectable and oral treatment supply chains. Our newer Active medical Ingredients (API) facility in Clayton, NC sits on 825,000 square-feet of state-of-the-art equipment, and houses the Fermentation, Recovery and Purification in the production of ingredients for Novo Nordisk’s innovative oral products.
At API, you’ll join a global network of manufacturing professionals who are passionate about what they do. What we offer you: Leading pay and annual performance bonus for all positions All employees enjoy generous paid time off including 14 paid holidays
Health Insurance, Dental Insurance, Vision Insurance – effective day one Guaranteed 8% 401K contribution plus individual company match option Family Focused Benefits including 12 weeks paid parental & 6 weeks paid family medical leave Free access to Novo Nordisk-marketed medical products Tuition Assistance – reimbursement Life & Disability Insurance Employee Referral Awards At Novo Nordisk, you will find opportunities, resources, and mentorship to help grow and build your career.
Are you ready to realize your potential? Join Team Novo Nordisk and help us make what matters. The Position Manage the governance, provide project oversite, drive the schedule & ensure adherence to the documented
requirements for system management of assigned IT Systems. This includes the full system lifecycle management process (system development, system maintenance & operation, compliance with regulatory & Novo Nordisk requirements, incident & change management & retirement of systems).
Ensure processes are in place for system maintenance & operation according to relevant regulatory authorities (Gx P, Financial, Personal Data Protection, etc. ). Relationships Reports to Manager, Automation System Magement API. Essential Functions Manages the IT system requirements by ensuring system compliance with relevant SOPs & guidelines, as well as external requirements (system security, audit trail, data integrity/retention/archival/restoration, patching, system monitoring, system continuity & contingency plan, etc.
) Works with IT Security/SME to ensure appropriate system security controls are in place & documented Ensures appropriate validation approach & qualification testing is in place to ensure IT requirements are met (i. e. FAT, SAT, UAT, IQ, OQ, PQ and/or GEP) Manages the system lifecycle process & provides strategic perspective for the IT roadmap Manages system change control with a risk-based approach Reviews & approves testing protocols to ensure requirements are tested appropriately Manages the system configuration & supports determining the configurable items that are documented in the configuration baseline standards Manages the system documentation (operation & maintenance standards, specifications, configuration baselines, instructional manuals, system architecture, data flows, system backssments, etc.
) Works closely with Subject Matter Expert (SME) to ensure system documentation complies with local, corporate & regulatory regulations Ensures user training & user support are in place Manages the approval of access for new users & performs user access reviews to determine access removal Ensures continued & improved overall user satisfaction with system Works with cross-functional project teams for process improvement Works closely with SME to understand & determine solutions for IT incidents & deviations, to ensure effective corrective actions are identified & implemented to prevent incident recurrence Supports establishing support standards & processes (internal & external support contracts/service level agreements (SLA), licensing contracts, incident handling, etc.
) Serves as primary escalation point for system support, improvements & projects Ensures that the validated state is maintained & monitored according to the established requirements by managing the Periodic System Evaluations (PSE) & reviewing system data to ensure IT controls are actively functioning as designed to ensure compliance with the documented system requirements Evaluates system alarms, user access, deviations & trends Supports audits & inspections Manages the project portfolio for the system (software upgrades, managing hardware obsolescence, retirement, etc.
) Maintains a safe work environment Other accountabilities, as assigned Physical Requirements Moves equipment &/or supplies weighing up to 33 pounds within the facility using various body positions.
Ability to do close precision work with their hands. Must be able to remain in a stationary position (sitting and standing) 50% of the time. May required corrected vision to 20/25 based on role. May require color vision based on role. Occasionally ascends/descends a ladder. May be required to work at elevated heights. Occasionally works around odorous &/or hazardous materials. Qualifications BA/BS degree in computer science/engineering/related field, equivalent combination of experience & education, or 5 years medical IT system management experience focusing on compliance preferred Minimum of five (5) years of engineering experience operation & maintenance of IT systems preferred Minimum of five (5) years of medical industry experience (Gx P) preferred Minimum of five (5) years of supporting & troubleshooting automation/IT systems & batch processes is a plus Proficient at troubleshooting (systematic problem solving) automated/IT system issues, including interfaces & hardware components preferred Understanding of IT frameworks such as COBIT, ITIL, GAMP, 21CFR Part 11, &/or PIC/S Annex 11 is a plus Functional knowledge of API processes & batch sequencing is a plus Expert in system development & lifecycle management including validation of computer systems, operation & maintenance & retirement preferred Functional understanding of the application of statistical analysis to problem solving preferred Expert in Gx P documentation practices required Excellent oral & written communication skills required Experience in regulatory audits & inspections required Expert in planning/organizing critical path milestones & resource demands, developing detailed schedules, managing task execution, process confirming results, adapting to the agility of a production environment, working with cross functional teams & revising the work plan for unplanned complex problems required We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in.
Together, we’re life changing. Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, interaction, gender identity, interactionual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations. If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at -xyz X.
This contact is for accommodation requests only and cannot be used to inquire about the status of applications.
manufacturing facilities that are responsible for fulfilling different steps in our injectable and oral treatment supply chains. Our legacy Injectable Finished Products (IFP) facility in Clayton, NC is a 457,000 square foot aseptic " fill and finish" site that is responsible for producing innovative, injectable diabetes and obesity treatments.
At IFP, you’ll join a global network of manufacturing professionals who are passionate about what they do. What we offer you: Leading pay and annual performance bonus for all positions All employees enjoy generous paid time off including 14 paid holidays Health Insurance, Dental Insurance, Vision Insurance – effective day one Guaranteed
8% 401K contribution plus individual company match option Family Focused Benefits including 12 weeks paid parental & 6 weeks paid family medical leave Free access to Novo Nordisk-marketed medical products Tuition Assistance Life & Disability Insurance Employee Referral Awards At Novo Nordisk, you will find opportunities, resources, and mentorship to help grow and build your career.
Are you ready to realize your potential? Join Team Novo Nordisk and help us make what matters. The Position Execute assigned projects across any business unit within cost, quality, & schedule requirements. Coach & support PM1s & PM2s in planning & executing projects to ensure project success (i. e. on budget,
on time, within scope). Partner with Line of Business to guide projects.
Ensure projects are executed & staffed according to plan. Support Line of Business in developing project roadmap & area master plan. Indirect reporting of PMO staff with 1:1s, roadblock resolution, risk reporting, & overall first level of project guidance. Relationships Reports to Manager, Project Management Office. Essential Functions Project Management: Lead multi-disciplined project teams to complete projects on-time, on-budget, meeting all requirements (quality, cost, schedule) Refine business case with project owner/sponsor Establish & communicate quantifiable project benefits Manage, coordinate & direct contract resources, & internal resources Refine & clarify project scope through early project analysis with subject matter experts & owners to further substantiate project purpose Provide clear goals so that the project secures effective use of time & resources & builds employee motivation Develop bid packages, bid evaluation & drive vendor selection.
Also work with procurement to create project specific contracts Accountable for financial project through purchase order creation, management, invoicing & cost forecasting Monitor & control project work with stringent follow-up on quality, schedule & budget so that the project delivers the desired end-product Monitor & report project progress, communications to management & other stakeholders, & presentation in steering groups Program Management: Lead programs, or series of related projects spanning multiple years, with specific oversight of quality, delivery, & cost Ensure alignment with global programs & other site projects Partner with business areas to visualize project roadmaps (i.
e. 1-3 year plan) & master plan (3+ year) Establish & maintain a project related downtime tracking tool Lead communications for business area stakeholders related to overall project delivery Indirect Reporting of PMO Staff: Primary communication & escalation path with PMO staff via 1:1, board meetings, etc.
Ensure the quality/content of steering group status & gate presentations Consult PMO manager on PM assignments & performance Process confirm use of the PMO tools & standards Review, approve, & endorse project related procurement (i. e. purchase orders & bid events) Follow all safety and environmental requirements in the performance of duties Other accountabilities, as assigned Physical Requirements Ability to work hours necessary to support production & /or project implementation windows.
Ability to move throughout facility in the performance of duties in proximity of process equipment & areas. Ability to travel internationally, up to 10% of the time. Ability to work in an open office environment with the possibility of frequent distraction. Ability to work the hours necessary to support a 24/7 continuous manufacturing operation. Ability to adjust schedule to work with colleagues in other international time zones. Occasionally moves equipment &/or supplies weighing up to 33 pounds within the facility using various body positions.
Constantly operates a computer & other office equipment using hands. Qualifications Bachelor’s degree in Engineering or other Technical Science field of study from an accredited university required; or May consider an Associate’s degree in Engineering Technology or other Technical Science field of study from an accredited university with an additional two years of proven project management experience required; or May consider a High School Diploma or GED with a minimum of four (4) additional years’ experience of proven project management required Minimum of eight (8) years of proven project management experience required, to include: Leading change management projects (process improvement, product transfer, IT/process automation Leading complex & major capital expenditure projects Minimum of three (3) years of experience in medical or biotechnology environment required Advanced project management competencies obtained through relevant project management training or experience preferred Excellent writing & oral communication skills; presentation & facilitation skills; & negotiation & conflict resolution skills required Ability to work in both technical & non-technical areas preferred Ability to use creativity to resolve problems that arise during project execution preferred Knowledge of Lean principles & how they apply in a manufacturing environment preferred Understanding of product documentation & standard operating procedures preferred Ability to create & manage work plans & detailed project schedules required Strong analytical/reasoning, organizational & multi-tasking skills required Demonstrated ability to communicate with key stakeholders in a cross-cultural environment & demonstrates superior written & oral communication skill required Develops & maintains strong internal & external relationship required Proficient in basic computer skills including experience with Microsoft Office required Proven project management experience with direct management of multiple projects simultaneously required Proven expertise in mentoring/development, planning/organizing, managing execution & revising the work plan for complex problems solved by cross functional teams preferred Ability to function independently, as well as execution of good judgement in decision making & strong leadership skills required Functions well in team environment required We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing. Novo Nordisk is an equal opportunity employer.
Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, interaction, gender identity, interactionual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations. If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at -xyz X. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.
Management & Executive Jobs refer to positions within an organization where individuals are tasked with making strategic decisions, overseeing operations, and leading teams towards achieving business goals. These roles typically include titles such as manager, director, vice president, and CEO, and are characterized by their high level of responsibility, authority, and often, a requirement for extensive experience and leadership skills. Executives set the vision for the company, while managers implement strategies and policies to drive success. These jobs often involve complex problem-solving, strong communication abilities, and the capacity to influence and motivate others.
Management & Executive Jobs encompass a range of high-level positions within organizations, typically involving the responsibility for strategic planning, decision-making, and leading teams or entire departments. Individuals in these roles are expected to possess strong leadership skills, the ability to think critically and strategically, as well as excellent communication abilities. Executives often have a significant influence on company culture, operations, and financial success. These roles include titles such as CEO, CFO, COO, Managing Director, as well as various managerial positions across different departments such as sales, marketing, human resources, and more.
Management & Executive Jobs encompass a range of high-level positions within organizations, typically involving the responsibility for strategic planning, decision-making, and leading teams or entire departments. Individuals in these roles are expected to possess strong leadership skills, the ability to think critically and strategically, as well as excellent communication abilities. Executives often have a significant influence on company culture, operations, and financial success. These roles include titles such as CEO, CFO, COO, Managing Director, as well as various managerial positions across different departments such as sales, marketing, human resources, and more.
Management & Executive Jobs refer to high-level positions within an organization that involve overseeing operations, making strategic decisions, and leading teams towards achieving business objectives. Individuals in these roles typically have significant experience and expertise in their respective fields. They are responsible for setting goals, developing policies, and ensuring the effective management of resources. Executive roles often include titles such as CEO, CFO, COO, and department heads, among others. Characteristically, these jobs demand strong leadership skills, excellent communication abilities, and a capacity to think critically and solve complex problems.
Management & Executive Jobs refer to positions at the higher echelons of an organization, where individuals are responsible for overseeing operations, formulating strategies, and making key decisions that affect the company's direction and success. These roles often require strong leadership skills, strategic thinking, and extensive experience in the industry. Executives and managers are pivotal in shaping organizational culture, motivating teams, and driving both short-term and long-term objectives. Characteristics of these positions include higher levels of responsibility, authority, and typically, a greater compensation package reflecting their critical role within the company.
Management & Executive Jobs refer to positions at the higher echelons of an organization, where individuals are responsible for overseeing operations, formulating strategies, and making key decisions that affect the company's direction and success. These roles often require strong leadership skills, strategic thinking, and extensive experience in the industry. Executives and managers are pivotal in shaping organizational culture, motivating teams, and driving both short-term and long-term objectives. Characteristics of these positions include higher levels of responsibility, authority, and typically, a greater compensation package reflecting their critical role within the company.
Management & Executive Jobs refer to positions within an organization that involve overseeing operations, making strategic decisions, and leading teams or entire companies towards their objectives. These roles typically require a mix of leadership skills, industry experience, and strategic thinking. Executives and managers are often responsible for setting goals, organizing resources, managing personnel, and ensuring that their department or organization meets performance targets. Distinctive characteristics of these jobs include high responsibility, decision-making authority, and frequently, a corresponding higher level of compensation reflecting their critical role in an organization's success.
Management & Executive Jobs refer to positions within an organization that involve overseeing operations, making strategic decisions, and leading teams or entire companies towards their objectives. These roles typically require a mix of leadership skills, industry experience, and strategic thinking. Executives and managers are often responsible for setting goals, organizing resources, managing personnel, and ensuring that their department or organization meets performance targets. Distinctive characteristics of these jobs include high responsibility, decision-making authority, and frequently, a corresponding higher level of compensation reflecting their critical role in an organization's success.
Management & Executive Jobs refer to positions at the higher echelons of an organization, where individuals are responsible for overseeing operations, formulating strategies, and making key decisions that affect the company's direction and success. These roles often require strong leadership skills, strategic thinking, and extensive experience in the industry. Executives and managers are pivotal in shaping organizational culture, motivating teams, and driving both short-term and long-term objectives. Characteristics of these positions include higher levels of responsibility, authority, and typically, a greater compensation package reflecting their critical role within the company.
Management & Executive Jobs refer to positions within an organization that involve overseeing operations, making strategic decisions, and leading teams or entire companies towards their objectives. These roles typically require a mix of leadership skills, industry experience, and strategic thinking. Executives and managers are often responsible for setting goals, organizing resources, managing personnel, and ensuring that their department or organization meets performance targets. Distinctive characteristics of these jobs include high responsibility, decision-making authority, and frequently, a corresponding higher level of compensation reflecting their critical role in an organization's success.
